SavvyHealth App for Multiple Sclerosis

(SavvyHealth Trial)

Overseen By Chungyi Chiu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new app called SavvyHealth to determine if it helps people with multiple sclerosis (MS) manage their health more effectively. Participants will either use the app for 21 days or join a waiting list. The goal is to assess whether the app improves life for those managing MS. Individuals diagnosed with MS and willing to use an app for a few weeks may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing MS symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SavvyHealth App is safe for people with multiple sclerosis?

Research shows that the SavvyHealth app is a digital health tool designed for people with multiple sclerosis. As a new app, it lacks specific safety data from past studies. However, the trial is labeled "Not Applicable" in terms of phases, indicating minimal risk. This is common for digital tools, as they don't involve drugs or medical procedures.

Digital health apps are generally easy to use and safe, requiring only a smartphone or computer. Users might encounter minor issues, such as technical glitches or difficulty navigating the app, but these do not pose health risks. Based on similar apps, the SavvyHealth app should be safe to use. For any concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SavvyHealth app for multiple sclerosis (MS) because it offers a unique way to manage the condition through a digital platform. Unlike traditional treatments that often focus on medication or physical therapy, SavvyHealth provides a personalized, interactive approach that empowers patients to track symptoms, access educational resources, and connect with healthcare providers right from their smartphones. This digital tool could potentially enhance patient engagement and self-management, offering a convenient and user-friendly complement to existing MS therapies. By integrating technology into disease management, SavvyHealth aims to make daily life easier for those living with MS, which is why it's generating interest in the medical community.

What evidence suggests that the SavvyHealth App is effective for multiple sclerosis?

Research shows that digital health tools can assist people with multiple sclerosis (MS) by providing personalized information and resources. In this trial, participants in the SavvyHealth arm will use the app for 21 days to manage their MS with a personalized health library, aiding informed health decisions. While specific data on the SavvyHealth app's effectiveness is limited, similar digital tools have shown promise in managing chronic conditions. Early feedback indicates that users find these apps helpful for gaining control and understanding their health better. Therefore, SavvyHealth might offer similar benefits for those managing MS. ^{1 2 3 5 6}

Who Is on the Research Team?

Chungyi Chiu

Principal Investigator

University of Illinois at Urbana-Champaign

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple sclerosis (MS) who are willing to use a new health e-library app, SavvyHealth, and take surveys. Participants must have at least one other health condition alongside MS and be open to being randomly placed in either the intervention or control group.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

I am open to being placed in any group of the study.

I am willing to complete a survey.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the SavvyHealth app for 21 days

3 weeks

2 visits (virtual)

Follow-up

Participants are monitored for changes in self-management skills after app usage

1 week

What Are the Treatments Tested in This Trial?

Interventions

• SavvyHealth

Trial Overview The study is testing the effectiveness of SavvyHealth, an individualized-health e-library app designed for people with MS. The goal is to see if using the app for three weeks can help manage their condition better than not using it.

How Is the Trial Designed?

Group I: SavvyHealth Experimental Treatment 1 Intervention

Participants will use the new app, SavvyHealth, for 21 days.

Group II: Waiting list Active Control 1 Intervention

Participants will be on the waiting list.

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Published Research Related to This Trial

The BRISA app, used by 2095 multiple sclerosis patients in Germany, revealed that most users are female and aged between 26 and 55, with relapsing-remitting MS being the most common type.

The study identified fatigue, concentration disorders, tingling, forgetfulness, and pain as the top symptoms affecting users, emphasizing the need for personalized disease management strategies based on real-world data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. Balakrishnan, P., Groenberg, J., Jacyshyn-Owen, E., et al.[2022]

A study involving 98 participants with multiple sclerosis found that performance expectancy and social influence are significant predictors of acceptance for mobile health apps, indicating that users are more likely to adopt these tools if they believe they will be helpful and if they receive social support.

Despite high smartphone usage (92% of participants), 63% had no experience with MS apps, highlighting a gap in utilization that could be addressed by improving perceptions of the apps' benefits and fostering social encouragement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of Mobile Health Apps for Disease Management Among People With Multiple Sclerosis: Web-Based Survey Study. Apolinário-Hagen, J., Menzel, M., Hennemann, S., et al.[2020]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

The IDoThis app, developed for self-management of multiple sclerosis (MS), was positively received by 75% of participants, indicating it effectively improved their MS self-management status after three weeks of use.

The app includes valuable features like training modules and condition monitoring, but users expressed a need for additional content on fatigue and sleep management to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile app (IDoThis) for multiple sclerosis self-management: development and initial evaluation. Salimzadeh, Z., Damanabi, S., Ferdousi, R., et al.[2022]

The digital health application 'levidex' was found to be practical and acceptable for people with multiple sclerosis (pwMS) with moderate to severe disability, as evidenced by positive participant feedback and a completion rate of 47.4% for all modules over a six-month period.

While the study showed that levidex could facilitate health behavior changes, no significant improvements were observed in secondary outcomes like empowerment or stress management, indicating the need for further research with larger sample sizes and longer follow-up to assess its true efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study. Kutzinski, M., Krause, N., Riemann-Lorenz, K., et al.[2023]

A randomized controlled trial involving 48 individuals with multiple sclerosis found that a tablet app-based training program did not significantly improve overall arm and hand function compared to a control strengthening exercise program.

However, the app-based training showed effectiveness in enhancing specific skills like fine coordinated finger movements and grip strength, suggesting it can be a useful home-based option for individuals with MS looking to improve dexterity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet app-based dexterity training in multiple sclerosis (TAD-MS): a randomized controlled trial. van Beek, JJW., Lehnick, D., Pastore-Wapp, M., et al.[2022]

The TEAMS (Tele-Exercise and Multiple Sclerosis) app was developed through a user-centered design process involving 21 participants, including 10 with multiple sclerosis, to create personalized exercise programs that accommodate varying functional limitations.

Usability testing showed significant improvement, with a 53% reduction in problems reported by participants in the second test, indicating that the app is effective and user-friendly for promoting home-based exercise among people with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEAMS (Tele-Exercise and Multiple Sclerosis), a Tailored Telerehabilitation mHealth App: Participant-Centered Development and Usability Study. Thirumalai, M., Rimmer, JH., Johnson, G., et al.[2019]

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

A wellness program for people with multiple sclerosis (MS) showed significant improvements in various health domains, including functional status, fatigue, and depression, based on data from 65 participants.

The program's focus on education and self-efficacy helped reduce fear-avoidance beliefs and pain, suggesting that a multidimensional approach can enhance overall well-being in MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. Hart, DL., Memoli, RI., Mason, B., et al.[2021]

The FlywheelMS study is collecting a large, deidentified health record data set from 5000 adults with multiple sclerosis (MS) across the U.S., utilizing a patient-centric platform to improve understanding of disease patterns and care.

As of November 2020, over 4176 participants have enrolled, with a high data abstraction precision of 97.8%, indicating that this method can reliably generate valuable insights for MS research and potentially for other diseases in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generating real-world data from health records: design of a patient-centric study in multiple sclerosis using a commercial health records platform. Hanson, G., Chitnis, T., Williams, MJ., et al.[2022]

In a study of 234 newly diagnosed multiple sclerosis (MS) patients, significant health behavior issues were identified, including high rates of smoking (19%), obesity (15%), and insufficient physical activity (36%), indicating a need for targeted lifestyle interventions.

The research highlighted that higher disability scores (EDSS) were linked to worse health outcomes, such as increased T2-lesion burden and lower quality of life, suggesting that individualized counseling on health behaviors could improve patient outcomes in early MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of health behaviour and clinical manifestation in early multiple sclerosis in Germany - Baseline characteristics of the POWER@MS1 randomised controlled trial. Krause, N., Derad, C., von Glasenapp, B., et al.[2023]

The study found that e-health literacy significantly differed between technology users and nonusers among 156 participants with multiple sclerosis, indicating that those who use tablets and recommended websites have better health literacy.

Participants' e-health literacy scores were weakly correlated with age, marital status, and education level, suggesting that these factors may influence how well individuals with MS can access and understand health information online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Health Literacy Status of Individuals with Multiple Sclerosis in Turkey. Tosun, AT., Isiklar, C., Yildirim, M., et al.[2023]

Citations

1. policylab.us policylab.us/clinical-trials/l/conditions/multiple-sclerosis

Multiple Sclerosis Clinical Trials - Policy Lab ... individualized-health e-library app named SavvyHealth among people with multiple sclerosis. The purpose of this study is to assess the effectiveness after ...

2. withpower.com withpower.com/clinical-trials/for-multiple-sclerosis?page=3

Top Multiple Sclerosis Clinical Trials | Power The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22eHealth%22

San Mateo Clinical Trials ... individualized-health e-library app named SavvyHealth among people with multiple sclerosis. Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) ...

4. clinconnect.io clinconnect.io/conditions/multiple-sclerosis?page=2

Clinical Trials for Multiple Sclerosis | ClinConnect This clinical trial is studying a new app called SavvyHealth, designed to help people with Multiple Sclerosis (MS) manage their health more effectively. The ...

5. policylab.us policylab.us/clinical-trials/l/illinois/champaign

Champaign, IL Paid Clinical Trials - Policy Lab The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple ...

6. withpower.com withpower.com/clinical-trials/for-multiple-sclerosis-near-chicago-il?page=2

56 Multiple Sclerosis Trials near Chicago, IL The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple ...